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CTRI Number  CTRI/2024/07/071275 [Registered on: 25/07/2024] Trial Registered Prospectively
Last Modified On: 24/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Caffeine intake on post-caesaraean bowel movements 
Scientific Title of Study   A Randomized controlled trial to evaluate the effect of postoperative caffeine intake on the return of bowel movements post caesarean section 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1310-7550  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anusha Devalla 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Bibinagar 
Address  Faculty block, first floor Department of Obstetrics and Gynaecology, AIIMS Bibinagar

Hyderabad
TELANGANA
508126
India 
Phone  9321306634  
Fax    
Email  anushadevalla2@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Anusha Devalla 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Bibinagar 
Address  Faculty block, first floor Department of Obstetrics and Gynaecology, AIIMS Bibinagar

Hyderabad
TELANGANA
508126
India 
Phone  9321306634  
Fax    
Email  anushadevalla2@gmail.com  
 
Details of Contact Person
Public Query  
Name  Anusha Devalla 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Bibinagar 
Address  Faculty block, first floor Department of Obstetrics and Gynaecology, AIIMS Bibinagar

Hyderabad
TELANGANA
508126
India 
Phone  9321306634  
Fax    
Email  anushadevalla2@gmail.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  AIIMS BIBINAGAR 
Address  AIIMS BIBINAGAR, HYDERABAD METROPOLITAN REGION, TELANGANA, INDIA 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Anusha Devalla  All India Institute of Medical Sciences, Bibinagar-Hyderabad  Postoperative ward and labour room, Department of Obstetrics and Gynaecology, All India Institute of Medical Scienes, Bibinagar, Telangana, India
Hyderabad
TELANGANA 		 9321306634

anushadevalla2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS BibinagarHyderabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O90||Complications of the puerperium, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Caffeine  Caffeine 45mg diluted in 100 ml of hot water (no added sugar/milk) given at 4 hours, 8 hours and 12 hours in the post caesarean section. Abdomen will be auscultated for bowel sounds hourly, time to appearance of first bowel sound, passage of first flatus, passage of stools, duration of post operative stay 
Comparator Agent  Warm water  Warm water 100 ml will be given at 4 hours, 8 hours and 12 hours in the post caesarean section. Abdomen will be auscultated for bowel sounds hourly, time to appearance of first bowel sound, passage of first flatus, passage of stools, duration of post operative stay. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Undergoing a planned caesarean section at AIIMS Bibinagar under regional anaesthesia;
2. Singleton pregnancy
3. Gestational age more than 37 weeks
4. Body mass index less than and equal to 40
5. Surgery duration less than 90 minutes
6. Patients willing to participate
 
 
ExclusionCriteria 
Details  1. Known Gastrointestinal disorders including history of Chronic Constipation
2. Caffeine allergy
3. Prolonged estimated surgery time (More than 90 mins)
4. Patients refusing to give consent to participate in the study
5. Patients undergoing emergency caesarean section
6. Patients undergoing LSCS under general anesthesia
7. Patients undergoing LSCS under regional but converted to General anesthesia
8. Patients with any obstetric or medical high-risk factor related to pregnancy like Gestational diabetes, Pregnancy induced hypertension, including other known cerebrovascular and cardiovascular co-morbidities;
9. Those not able to tolerate oral intake or caffeine intake(intense epigastric pain, vomiting)
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the timing of passage of first flatus  hourly within first 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the timing of the first bowel movement (bowel sounds) heard in both the groups
To assess the timing of defaecation in both the groups;
To note the length of the hospital stay in both the groups
 		 within 6 hours, 12 hours, 24 hours, 48 hours & 72 hours. 
 
Target Sample Size   Total Sample Size="370"
Sample Size from India="370" 
Final Enrollment numbers achieved (Total)= "370"
Final Enrollment numbers achieved (India)="370" 
Phase of Trial   N/A 
Date of First Enrollment (India)   04/08/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
An effort to improve post operative recovery with respect to bowel movements has been studied in various clinical studies including prokinetic medications, Chinese medications, chewing gums and acupuncture. Coffee is one of the most common and cheapest beverages taken worldwide including India, in a few studies (reported outside India) it has been shown to improve the recovery of bowel function. Through the present study, we plan to evaluate the effectiveness of postoperative caffeine intake on the return of bowel function post uncomplicated Caesarean Section. If found effective, it may be potentially used as an alternative as a non-pharmacological agent.This will be the first study from Indian settings.
 
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